5/20/2018

There are concerns over how the United Kingdom’s (UK) departure from the European Union (EU), also known as Brexit, will affect clinical research stakeholders in the UK and the EU. Brexit will begin March 29, 2019. Since the European Medicines Agency (EMA) is a EU Agency, would that mean that the UK would no longer be a part of the Agency or follow the regulations set by it? What effects would the change have on harmonization of clinical trials through Europe and globally?

How does Brexit affect the EMA headquarters, and will it remain independent?

The headquarters for the EMA will move from London to Amsterdam as a result of Brexit once all measures are finalized. A Seat Agreement specifying the employment conditions for the EMA and its employees was signed by the Dutch Council of Ministers April 13, 2018, which brings it one step closer to finalizing the transition of the EMA to the Netherlands. Once signed by the EMA and the Netherlands, the Seat Agreement allows the EMA to function as an independent agency from the Netherlands.

How does separation from the EU affect UK’s Medicines and Healthcare products Regulatory Agency (MHRA)?

The Medicines and Healthcare products Regulatory Agency (MHRA) corporate plan explains that the Agency plans to redefine itself after Brexit in the following ways. The MHRA:

· is prepared to change its role in Europe and globally.

· will explore the possibility of new global partnerships.

· will strengthen its commitment to UK to expedite access to new drugs and devices.

The MHRA acknowledges that its exact role in the EU is yet to be determined and will be known once negotiations are complete, but they will prepare for all eventualities including the possibility of no agreement.

Will the UK follow the soon to be implemented EU Clinical Trials Regulation?

EU Clinical Trials Regulation (Regulation EU No 536/2014) should modernize, harmonize, and improve transparency for clinical trials once fully implemented. There is concern the EU Clinical Trials Regulation (EU 536/2014) may move into implementation after the UK withdraws from the EU. Although EU 536/2014 was adopted in 2014, it will be implemented six months after the European Commission publishes a notice that the EU Portal and Database are ready. This is expected to occur in 2019, which overlaps with the Brexit date of March 29, 2019.

· advance towards adopting EU regulations in the UK, including as much as possible of EU 536/2014.

Two parts of EU 536/2014, the shared EU Portal and Database and single assessment model, would require additional negotiations after Brexit between the UK and EU prior to implementation.

The UK Government intends to support patients and clinical trials stakeholders through the Brexit process, which the MHRA stands behind. Adoption of EU regulations in the post-Brexit UK would ensure harmonization of clinical trials across Europe. Reassurance that every possible measure will be taken to implement EU 536/2014 in the UK despite Brexit conveys that the UK’s government is committed to modernizing clinical research.